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SOURCE ThromboGenics NV
LEUVEN, Belgium, February 24, 2014 /PRNewswire/ --
Focus on Realizing the Commercial Potential of JETREA® in the US and Capitalizing on the Company's Proven Product Development Capabilities
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines for the back of the eye, today announced that the Board has decided to explore strategic options for the Company. This decision is intended to increase the Company's ability to realize the significant commercial potential of JETREA® in the US, and to fully capitalize on the Company's proven product development capabilities.
The Board has retained Morgan Stanley to help with the strategic review process.
ThromboGenics successfully developed JETREA®, the first and only pharmacological treatment indicated for symptomatic vitreomacular adhesion (VMA)/ vitreomacular traction (VMT) in the US and Europe respectively. Symptomatic VMA/VMT is a progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness. JETREA® offers an earlier and easy to administer treatment option, which avoids patients having to experience deterioration in their disease state to a point where a vitrectomy is the only solution.
ThromboGenics' strong clinical, regulatory and market access capabilities have led to the efficient development and approval of its lead drug JETREA®.
This novel drug has received positive health technology assessments leading to full reimbursement and coverage in the US, key markets in Europe and Canada. These assessments have highlighted the patient benefits of JETREA® including when used to treat patients with symptomatic VMA earlier. This experience will be important as ThromboGenics looks to broaden the retinal indications that JETREA®could be used for.
During 2013, ThromboGenics focused its efforts on the launch of JETREA®in the US where the company decided to launch the drug on its own.
2013 has been a learning year for ThromboGenics. The high level of awareness of JETREA® amongst the retina community in the US at the time of launch, has not yet delivered the sales volume that the Company had anticipated. In 2013, close to 7000 patients were treated with JETREA® in the US.
Clinical experience with the product to-date has shown that JETREA®is effective and safe, and ThromboGenics continues to believe that, despite the commercial challenges it has encountered to-date in the US, JETREA® will find its place as a new standard of care for the earlier treatment of symptomatic VMA/VMT.
Dr Patrik De Haes, CEO of ThromboGenics comments: "The Board has made this decision to explore alternative options for the Company to increase its ability to realize the significant commercial potential of JETREA® in the US market. We are starting the strategic exercise with an open mind. We will update the market in due course".
About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. JETREA® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
In the US and Canada, JETREA® is indicated for the treatment of symptomatic vitreomacular adhesion (VMA). In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter = 400 microns.
JETREA® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the US and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
JETREA's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA was generally well tolerated with most adverse events being transient and mild in severity.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States. Under this agreement, ThromboGenics will receive significant royalties from Alcon's net sales of JETREA®. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
Alcon has launched JETREA® in the UK, Germany, Italy, Finland, Denmark, Norway, Sweden and Canada.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of ophthalmic and oncology indications.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
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